2016 | Q4 Newsletter | Q & A's with Health Advisory Council Members
Senior Vice President, Policy & Strategic Alliances, Generic Pharmaceutical Association (GPhA), and Executive Director, The Biosimilars Council
Q. How would you describe your role at the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council?
A. I serve a dual function: I am both the Senior Vice President of Policy & Strategic Alliances at GPhA, as well as the Executive Director of the Biosimilars Council, a division of GPhA that works to support the development of a robust biosimilars market, and educate policymakers, consumers, patients, providers, and other stakeholders about how biosimilars can increase access to safe, effective and affordable treatments. The generic and biosimilar industries share the common mission of improving patient access to more affordable medicines, and reducing costs to the health system by driving competition in the marketplace.
In my GPhA capacity, I am responsible for leading policy development and issues management for our generic manufacturer members, as well as building relationships with strategic partners and stakeholders in the healthcare sector, such as NCL.
As the Executive Director of the Biosimilars Council, I work with its Board of Directors to position the organization as the leader and resource on biosimilars issues. I oversee the Council’s committees relating to education, advocacy, government and regulatory affairs, as well as our annual conference which provides a forum for biosimilar stakeholders to learn more about key issues.
Q. What do you think Council members should know about GPhA and the Biosimilars Council?
A. Generics and biosimilars drive savings, not costs. Our member companies produce approximately 90% of prescription drugs dispensed in the U.S. annually, and their products treat virtually every disease and condition. However, generics represent only 27% of drug costs. Our members are one of the few players in the healthcare system that are “bending the cost curve” and making medicines accessible for consumers.
Q. What GPhA initiatives would you like to share with the Council?
A. We are very excited to have recently completed negotiations with FDA on the second Generic Drug User Fee Program (GDUFA). While brand manufacturers have had user fee agreements with the agency for over two decades, this has been an important growth experience for the generics industry. FDA and generic manufacturers initially came together in 2012 when it became apparent that the existing generic drug application backlog at the agency was no longer sustainable, and was delaying patient access to lower-cost alternatives. However, while in recent months the agency has begun to sustain a noticeable uptick in generic approvals, that initial program definitely suffered from some growing pains. There is still a backlog at FDA, and approval times are still nowhere near the 180 days initially envisioned by Hatch-Waxman.
We believe that GDUFA II makes significant progress in improving and maintaining the program. However, the existing program expires on September 30, 2017, so Congress will need to pass legislation to enshrine the latest agreement before then, and it will be important for stakeholders to weigh-in to ensure that FDA has the necessary resources to enhance the science-based review of generic drugs, and address the generic drug backlog currently pending at the agency.
We look forward to continuing to work with NCL and stakeholders to ensure that GDUFA II moves easily through Congress and that the agency has the appropriate resources to comply with it.
Q. What is GPhA and the Biosimilars Council doing to change the way people think about and approach healthcare?
A. GPhA and the Biosimilars Council have been working very hard to raise awareness about the vastly different markets in which brand and generic manufacturers operate. Unlike brand manufacturers who do not have direct price-based competitors, generics function in an entirely different market where our members aggressively compete with one another on price. As more players enter any given market, the price lowers. As policymakers and stakeholders begin considering various solutions to address prescription drug costs, we’ve found that there is a significant lack of understanding and education surrounding the two different markets. We have been working hard with our allies to address that deficit to ensure that policy solutions seeking to address cost do not jeopardize the incredibly efficient and effective market that the generics industry has created. That system has created enormous value for patients and consumers, and reducing competition would only increase costs.
Q. What does GPhA and the Biosimilars Council value about membership in NCL’s Health Advisory Council?
A. As new members, we are looking forward to the opportunity to partner with NCL, and in particular the Health Advisory Council, to consider and support policies that will increase consumer access to safe, effective and affordable medicines.
Director of Programs and Operations, Caregiver Action Network
Q. How would you describe your role at the Caregiver Action Network (CAN)?
A. As Director of Programs and Operations, I am responsible for corporate outreach and relationship building. In addition, I manage various programs that CAN is involved in like distributing free meals to family caregivers, surveys, conducting workshops, and many other programs.
Q. What do you enjoy most about working at CAN?
A. I have been at CAN for a little over 6 years now. To me waking up every day and being able to go to a job that I love is very important. We are a small staff but like many other organizations – we are a true family. Being able to speak to family caregivers every day and provide them with help or just to listen to them vent is rewarding. To know that we help family caregivers as they struggle on this journey that they did not ask for is very satisfying.
Q. How would you describe CAN’s role in the advocacy arena?
A. CAN has created a 501(c)(4) (Caregiver Voices United) which allows us to advocate on family caregiving issues on a full time basis. Our current effort has been featured in the The Hill and Politico and on WTOP radio.
Q. What are the biggest challenges facing CAN today?
A. The biggest challenge we face at CAN is ensuring that family caregivers are not left out of the health care team discussions. A lot of focus is on professionals and the patient. However, in most cases it is the family caregiver who is making the medical and financial decisions for the patient and the family. The family caregiver or care partner is the one researching treatments or clinical trial information.
Q. What CAN initiatives would you like to share with the Council?
A. CAN was recently awarded a PCORI engagement grant to conduct 8 workshops entitled: Equipping You for Success: Training for Family Caregivers in Team-Based Medical Decisions.
Q. What do you believe is the most valuable aspect of CAN’s participation in NCL’s Health Advisory Council?
A. CAN appreciates the opportunity to remind Council members that the Family Caregiver voice has to be heard and respected.